PMID- 22572767
OWN - NLM
STAT- MEDLINE
DCOM- 20121113
LR  - 20220309
IS  - 1421-9824 (Electronic)
IS  - 1420-8008 (Linking)
VI  - 33
IP  - 2-3
DP  - 2012
TI  - Efficacy and safety of donepezil 23 mg versus donepezil 10 mg for 
      moderate-to-severe Alzheimer's disease: a subgroup analysis in patients already 
      taking or not taking concomitant memantine.
PG  - 164-73
LID - 10.1159/000338236 [doi]
AB  - BACKGROUND/AIMS: A large multicenter trial of donepezil 23 mg/day versus 
      donepezil 10 mg/day for moderate-to-severe Alzheimer's disease allowed patients 
      taking concomitant memantine. We evaluated the efficacy/safety of donepezil 23 
      and 10 mg/day in this trial, with respect to concomitant memantine use. METHODS: 
      Prespecified analysis of data from a 24-week, randomized, double-blind trial. 
      Patients were randomized to donepezil doses (23 vs. 10 mg/day) and stratified by 
      concomitant memantine use (yes or no). Efficacy and safety were assessed for each 
      donepezil dose in subgroups taking or not taking concomitant memantine. RESULTS: 
      At week 24, donepezil 23 mg/day provided significant cognitive benefits over 10 
      mg/day (p < 0.01) on the Severe Impairment Battery, with or without concomitant 
      memantine (ANCOVA adjusted for baseline score, country and treatment). The higher 
      dose showed no benefit on the global function, Mini-Mental State Examination or 
      activities of daily living measures in either memantine subgroup. Rates of 
      treatment-emergent adverse events (AEs) were higher for donepezil 23 mg/day with 
      memantine (80.7%) than 23 mg/day without memantine (69.7%) or 10 mg/day 
      with/without memantine (66.7/62.0%); across all treatment groups, most events 
      were mild/moderate in severity. Individual rates of serious AEs were low (<1.0%), 
      regardless of concomitant memantine use. CONCLUSION: In this population, 
      concomitant memantine use did not alter the response profile of donepezil 23 vs. 
      10 mg/day. Donepezil 23 mg was generally safe and well tolerated among patients 
      receiving donepezil alone and among patients receiving a combination of donepezil 
      and memantine therapy.
CI  - Copyright (c) 2012 S. Karger AG, Basel.
FAU - Doody, Rachelle S
AU  - Doody RS
AD  - Baylor College of Medicine, Houston, TX 07730, USA. rdoody@bcm.edu
FAU - Geldmacher, David S
AU  - Geldmacher DS
FAU - Farlow, Martin R
AU  - Farlow MR
FAU - Sun, Yijun
AU  - Sun Y
FAU - Moline, Margaret
AU  - Moline M
FAU - Mackell, Joan
AU  - Mackell J
LA  - eng
SI  - ClinicalTrials.gov/NCT00478205
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120510
PL  - Switzerland
TA  - Dement Geriatr Cogn Disord
JT  - Dementia and geriatric cognitive disorders
JID - 9705200
RN  - 0 (Indans)
RN  - 0 (Piperidines)
RN  - 8SSC91326P (Donepezil)
RN  - W8O17SJF3T (Memantine)
SB  - IM
MH  - Activities of Daily Living
MH  - Aged
MH  - Aged, 80 and over
MH  - Alzheimer Disease/diagnosis/*drug therapy/psychology
MH  - Donepezil
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Female
MH  - Geriatric Assessment/methods
MH  - Humans
MH  - *Indans/administration & dosage/adverse effects
MH  - Intelligence Tests
MH  - Male
MH  - *Memantine/administration & dosage/adverse effects
MH  - *Piperidines/administration & dosage/adverse effects
MH  - Psychiatric Status Rating Scales
MH  - Treatment Outcome
EDAT- 2012/05/11 06:00
MHDA- 2012/11/14 06:00
CRDT- 2012/05/11 06:00
PHST- 2012/03/15 00:00 [accepted]
PHST- 2012/05/11 06:00 [entrez]
PHST- 2012/05/11 06:00 [pubmed]
PHST- 2012/11/14 06:00 [medline]
AID - 000338236 [pii]
AID - 10.1159/000338236 [doi]
PST - ppublish
SO  - Dement Geriatr Cogn Disord. 2012;33(2-3):164-73. doi: 10.1159/000338236. Epub 
      2012 May 10.